medtronic
MiniMed 770G System User Guide Rev A
System User Guide
359 Pages
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Page 1
SYSTEM USER GUIDE
MiniMed™ 770G SYSTEM USER GUIDE
Copyright & trademarks © 2020 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. ™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. Bolus Wizard™, CareLink™, Dual Wave™, Guardian™, MiniMed™, Mio™, Quick-set™, Silhouette™, SmartGuard™, Square Wave™, and Sure-T™ are trademarks of Medtronic MiniMed, Inc. ACCU-CHEK and ACCU-CHEK GUIDE are trademarks of Roche. Wi-Fi™* Bluetooth™* Humalog™* NovoLog™* NovoRapid™* Android™* iOS™*
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Contacts: Africa: Medtronic South Africa and Southern Africa Office Reception Tel: +27(0) 11 260 9300 Diabetes: 24/7 Helpline: 0800 633 7867 Sub-Sahara 24/7 Helpline: +27(0) 11 260 9490 Albania: Net Electronics Albania Tel: +355 697070121 Argentina: Corpomedica S.A. Tel: +(11) 4 814 1333 Medtronic Directo 24/7: +0800 333 0752 Armenia: Exiol LLC Tel: +374 98 92 00 11 or +374 94 38 38 52 Australia: Medtronic Australasia Pty. Ltd. Tel: 1800 668 670 Bangladesh: Sonargaon Healthcare Pvt Ltd. Mobile: (+91)-9903995417 or (+880)-1714217131 Belarus: Zarga Medica Tel: +375 29 625 07 77 or +375 44 733 30 99 Helpline: +74995830400 België/Belgique: N.V. Medtronic Belgium S.A. Tel: 0800-90805 Bosnia and Herzegovina: "Novopharm“ d.o.o. Sarajevo Tel: +387 33 476 444 Helpline: 0800 222 33 Epsilon Research Intern. d.o.o. Tel: +387 51 251 037 Helpline: 0800 222 33 Brasil: Medtronic Comercial Ltda. Tel: +(11) 2182-9200 Medtronic Directo 24/7: +0800 773 9200 Bulgaria: RSR EOOD Tel: +359 888993083 Helpline: +359 884504344 Canada: Medtronic Canada ULC Tel: 1-800-284-4416 (toll free/sansfrais)
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Israel: Medtronic Tel. (orders): +9729972440, option 3 + option 1 Tel. (product support): +9729972440, option 2 Helpline (17:00 – 08:00 daily/weekends – Israel time): 1-800-611-888 Italia: Medtronic Italia S.p.A. Tel: +39 02 24137 261 Fax: +39 02 24138 210 Servizio assistenza tecnica: Nº verde: 800 60 11 22 Japan: Medtronic Japan Co. Ltd. Tel: +81-3-6776-0019 24 Hr. Support Line: 0120-56-32-56 Kazakhstan: Medtronic BV in Kazakhstan Tel: +7 727 311 05 80 (Almaty) Tel: +7 717 224 48 11 (Astana) Круглосуточная линия поддержки: 8 800 080 5001 Kosovo: Yess Pharma Tel: +377 44 999 900 Helpline: +37745888388 Latin America: Medtronic, Inc. Tel: 1(305) 500-9328 Fax: 1(786) 709-4244 Latvija: RAL SIA Tel: +371 67316372 Helpline (9am to 6pm): +371 29611419
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Schweiz: Medtronic (Schweiz) AG Tel: +41 (0)31 868 0160 24-Stunden-Hotline: 0800 633333 Fax Allgemein: +41 (0)318680199 Serbia: Epsilon Research International d.o.o. Tel: +381 113115554 Medtronic Serbia D.o.o Helpline: +381 112095900 Singapore: Medtronic International Ltd. Tel: +65 6436 5090 or +65 6436 5000 Slovenija: Zaloker & Zaloker d.o.o. Tel: +386 1 542 51 11 24-urna tehnična pomoč: +386 51316560 Slovenská republika: Medtronic Slovakia, s.r.o. Tel: +421 26820 6942 HelpLine: +421 26820 6986 Sri Lanka: Swiss Biogenics Ltd. Mobile: (+91)-9003077499 or (+94)-777256760 Suomi: Medtronic Finland Oy Tel: +358 20 7281 200 Help line: +358 400 100 313 Sverige: Medtronic AB Tel: +46 8 568 585 20 Fax: +46 8 568 585 11 Taiwan: Medtronic (Taiwan) Ltd. Tel: 02-21836000 Toll free: +886-800-005285 Thailand: Medtronic (Thailand) Ltd. Tel: +662 232 7400 Türkiye: Medtronic Medikal Teknoloji Ticaret Ltd. Sirketi. Tel: +90 216 4694330 USA: Medtronic Diabetes Global Headquarters 24-Hour Technical Support: +1-800-646-4633 To order supplies: +1-800-843-6687
Ukraine: Med Ek Service TOV Tel: +380 50 3311898 or +380 50 4344346 Лінія цілодобової підтримки: 0 800 508 300 United Kingdom: Medtronic Ltd. Tel: +44 1923-205167 Österreich: Medtronic Österreich GmbH Tel: +43 (0) 1 240 44-0 24 – Stunden – Hotline: 0820 820 190 Česká republika: Medtronic Czechia s.r.o. Tel: +420 233 059 111 Non-stop helpLine (24/7): +420 233 059 059 Zákaznický servis (8:00 - 17:00): +420 233 059 950
■
■
■ Contents
Contents Before you begin 3
Using this user guide
5
Acronyms and abbreviations
5
Emergency kit
7
User safety
7
Intended use
7
Contraindications
8
Potential risks
11
General warnings
17
General precautions
20
Security precautions
21
Adverse reactions
21
Keeping track of your system information
22
Insulin guidelines
22
Consumables
24
Additional MiniMed 770G System devices
24
Accessories
25
Ordering supplies and accessories
First steps 29
Your pump
30
Using the buttons
31
About batteries Contents
v
■
32
Inserting the battery
33
Removing the battery
34
Getting to know your pump
35
Entering your startup settings
37
Unlocking your pump
37
Home screen
38
Status icons
43
Using the menu
44
Status screens
46
Modes
47
Manual Mode
50
SmartGuard Auto Mode
51
Scroll bar
52
Power modes
52
If you remove your pump
Basal
vi
57
Basal rate
58
Basal insulin settings
59
Max Basal rate
59
Example 1: Max basal rate
60
Example 2: Max basal rate
60
Basal patterns
61
Adding a new basal pattern
64
Editing, copying, or deleting a basal pattern
64
Changing from one basal pattern to another
65
Example 1: Basal patterns
65
Example 2: Basal patterns
65
Temp basal rates
66
About temp basal rates
67
Example 1: Temp basal rates
67
Starting a temp basal rate Contents
■
68
Preset temp basal rates
71
Canceling a temp basal or preset temp basal rate
71
Viewing your basal information
72
Stopping and resuming your insulin delivery
Bolus About bolus deliveries
77
Bolus types
78
Bolus type example
79
Bolus delivery options
81
Bolus settings
82
Max bolus
83
Example 1: Max bolus
83
Example 2: Max bolus
83
Bolus increment
84
Bolus speed
84
Bolus Wizard feature
84
Understanding your Bolus Wizard settings
85
Setting up the Bolus Wizard feature
88
Changing your Bolus Wizard settings
90
Turning off the Bolus Wizard feature
90
About active insulin
91
Bolus Wizard feature alerts
92
Normal bolus
92
Delivering a Normal bolus with the Bolus Wizard feature
95
Delivering a Normal bolus using Manual Bolus
95
Square Wave bolus
96
Turning on or off the Square Wave bolus feature
96
Delivering a Square Wave bolus with the Bolus Wizard feature
98
Delivering a Square Wave bolus using Manual Bolus
98
Dual Wave bolus
99
Turning on or off the Dual Wave bolus feature
■ Contents
77
Contents
vii
■
■
■
99
Delivering a Dual Wave bolus with the Bolus Wizard feature
100
Delivering a Dual Wave Bolus using Manual Bolus
101
Easy Bolus feature
102
Understanding the Easy Bolus step sizes
102
Setting up the Easy Bolus feature
103
Delivering a bolus using the Easy Bolus feature
104
Preset bolus
104
Setting up and managing preset bolus deliveries
106
Delivering a preset bolus
106
Stopping a bolus delivery
Reservoir and infusion set 111
Setting up the reservoir and infusion set
124
Disconnecting your infusion set
124
Reconnecting your infusion set
Meter 127
About your Accu-Chek Guide Link meter
128
Pairing your pump and meter
130
Deleting a meter from your pump
130
Deleting your pump from a meter
History and events
viii
133
History
133
Summary screen
134
Understanding the Summary screen
137
Daily History
137
Alarm History
138
Sensor Glucose Review
139
ISIG History
140
Event Markers
Contents
■
■
145
Personal reminders
146
Bolus BG Check reminder
147
Missed Meal Bolus reminder
147
Low Reservoir reminder
148
Set Change reminder
149
Calibration reminder
■ Contents
■
Reminders
General settings 153
Audio Options
153
Auto Suspend
154
Block Mode
155
Display Options
155
Language
156
Managing your pump settings
160
Upload to CareLink software
160
Self Test
161
Sensor Demo
162
Time and date
Setting up CGM 165
Understanding CGM
166
SmartGuard Technology
167
Home screen with CGM in Manual Mode
170
Understanding glucose settings
171
High SG settings
172
Low SG settings
183
Turning on the Sensor feature
183
Setting up the high SG settings
186
Setting up the low SG settings
Contents
ix
■
■
189
Manually resuming basal insulin delivery during a SmartGuard suspend event
190
Pairing your pump and transmitter
193
Deleting the transmitter from your pump
193
Inserting the sensor
193
Connecting the transmitter to the sensor
193
Starting the sensor
194
Reconnecting the sensor
194
Calibrating your sensor
195
Where to enter your calibration BG meter reading
197
When to calibrate
198
Guidelines for calibrating
198
Disconnecting the transmitter from the sensor
198
Removing the sensor
198
Turning off Sensor Settings
Using CGM 203
The sensor graph
204
Identifying rapid changes in SG
205
Silencing glucose alerts
SmartGuard Auto Mode
x
211
About SmartGuard Auto Mode
212
Manual Mode
212
Before using SmartGuard Auto Mode
213
Setting up SmartGuard Auto Mode
214
Conditions to activate SmartGuard Auto Mode
215
SmartGuard suspend features and SmartGuard Auto Mode
215
SmartGuard Auto Mode Readiness
217
Home screen with SmartGuard Auto Mode
218
Using SmartGuard Auto Mode
218
Safe Basal
Contents
■
Example: Safe Basal
220
Block Mode when in SmartGuard Auto Mode
220
Setting Temp Target
222
SmartGuard Auto Mode sensor graph
223
Enter BG
224
SmartGuard Auto Mode Bolus
226
Alert Silence
229
Exiting SmartGuard Auto Mode
229
Returning to SmartGuard Auto Mode
■ Contents
■
220
Alarms, alerts, and messages 233
About alarms, alerts, and messages
234
Alarms
235
Alerts
236
Messages
236
Pump alarms, alerts, and messages
254
CGM (sensor) alarms, alerts, and messages
265
SmartGuard Auto Mode alerts and messages
270
CareLink software alert and message
Troubleshooting 275
Troubleshooting pump issues
276
My pump buttons are stuck
276
What is a Check Settings alarm?
276
My pump is asking me to rewind
277
I dropped my pump
277
I cannot get to the Manage Settings screen
277
My pump display times out too quickly
278
Where is my pump status screen?
278
My pump is asking me to enter my settings
280
Troubleshooting sensor issues
280
My pump cannot find the sensor signal
Contents
xi
■
■
281
Calibration not accepted
281
Why does the SmartGuard suspend icon on my Home screen appear gray?
Maintenance 285
Cleaning your pump
286
Cleaning your transmitter
286
Storing your pump
287
Storing your transmitter
288
Pump disposal
Product specifications and safety information
xii
291
Product specifications
291
Alarm and alert escalation
292
Altitude range
292
Audio frequency
293
Backlight
294
Basal insulin delivery
294
BG Target
294
BG meter value
295
Bolus delivery
295
Bolus Wizard feature default settings
295
Bolus Wizard feature specifications
298
Carb ratios
298
Delivery accuracy
299
Easy Bolus feature
300
Environmental conditions
300
Essential performance
300
Filling the infusion set and cannula
301
Infusion pressure
301
Insulin delivery default settings
302
Insulin sensitivity factor
Contents
Low Reservoir reminder
303
Max bolus
303
Normal bolus
303
Occlusion detection
304
Percent temp basal rate
304
Program safety checks
304
Pump dimensions
304
Pump memory
304
Pump weight
304
Sensor default settings
307
Wireless communication
307
IEC60601-1-2:4th Edition notice
307
IEC60601-1-2:4th Edition; Special EMC Precautions for Medical Electrical Equipment
307
IEC60601-1-2:4th Edition; 5.2.1.1
308
Guidance and manufacturer's declaration
312
Icon table
■ Contents
■
302
Appendix A: Open Source Software disclosure 317
Open Source Software disclosure
■
Glossary
■
Index
Contents
xiii
xiv
Contents
Before you begin
■ Before you begin
Before you begin This user guide is designed to help you understand the operation of the MiniMed 770G System with smart device connectivity and SmartGuard technology, our latest advancement in diabetes management. In the MiniMed 770G System, SmartGuard technology can automatically adjust basal insulin delivery based on your sensor glucose (SG) values. The SmartGuard feature can be used in two modes: Manual Mode or Auto Mode. Work closely with your healthcare professional when you start insulin pump therapy. In this user guide, the term Auto Mode refers to the automatic control of basal insulin delivery. For more information, see About SmartGuard Auto Mode, on page 211. When your pump is not operating in Auto Mode, the term Manual Mode is used to describe its functions.
Using this user guide This user guide contains valuable information about using your new insulin pump. To help you find the information you need, you can use the table of contents at the beginning of the user guide and the index at the end of the user guide. There is also a glossary of terms, which starts on page 321. The following table describes certain terms, conventions, and concepts used in this user guide. Convention
What it means
Select
To activate a screen item, accept a value, or initiate an action.
Select and hold
To perform an action using your pump screen, press the Select button and hold until the action is complete.
Before you begin
3
Convention
What it means
Press
To push and then release a button.
Press and hold
To push and keep pressure on a button.
Bold text
To indicate screen items and buttons. For example, "Select Next to continue."
X
To indicate a numeric value or name that appears differently on your pump screen.
Note
Note: A note provides helpful information.
Caution
CAUTION: A caution tells you of a potential hazard which, if not avoided, may result in minor or moderate injury or damage to the equipment.
WARNING
WARNING: A warning tells you of a potential hazard which, if not avoided, could result in death or serious injury. It may also describe potential serious adverse reactions and safety hazards.
The MiniMed 770G System User Guide includes instructions on how to set up devices on the MiniMed 770G insulin pump. For additional instructions not included in the MiniMed 770G System User Guide, refer to the instructions for the device.
4
Device
For instructions see
Reservoir
Reservoir user guide
Infusion Sets
Infusion set user guide
Transmitter
Guardian Link (3) transmitter user guide
Sensor
Guardian Sensor (3) user guide
Chapter 1
Device
For instructions see
Meter
Accu-Chek® Guide Link User's Manual
Acronyms and abbreviations The following table defines acronyms and abbreviations used in this guide. Definition
■ Before you begin
Acronyms and abbreviations BG
blood glucose
CGM
continuous glucose monitoring
CT scan
computerized tomography scan
DKA
diabetic ketoacidosis
EMC
electromagnetic compatibility
ESD
electrostatic discharge
FCC
Federal Communications Commission
GPS
global positioning system
ISIG
input signals, which are read from the sensor and measured in nanoamperes (nA)
IV
intravenous
MRI
magnetic resonance imaging
NiMH
nickel-metal hydride
RF
radio frequency
SG
sensor glucose
SN
serial number
TDD
total daily dose
Emergency kit Keep an emergency kit with you at all times to make sure that you always have necessary supplies. Tell a family member, co-worker, or friend where you keep your emergency kit.
Before you begin
5
It is important that you test your blood glucose (BG) more frequently while you travel. The routine hassle of travel, including stress, changes in time zones, schedules and activity levels, meal times and types of food, can all affect your diabetes control. Be extra attentive to monitoring your BG frequently, and be prepared to respond if needed. Your emergency kit should include these items: •
Fast-acting glucose tablets
•
BG monitoring supplies
•
Urine or blood ketone monitoring supplies
•
Extra MiniMed infusion set and MiniMed reservoir
•
Extra new AA lithium or alkaline batteries, or fully charged NiMH batteries
•
Insulin syringe and rapid-acting insulin (with dosage instructions from your healthcare professional)
•
Adhesive dressing
•
Glucagon emergency kit WARNING: Do not use the Bolus Wizard feature to calculate a bolus for a period of time after giving a manual injection of insulin by syringe or pen. Manual injections are not accounted for in the active insulin amount. Therefore, the Bolus Wizard feature could prompt you to deliver more insulin than needed. Too much insulin can cause hypoglycemia. Consult with your healthcare professional for how long you need to wait after a manual injection of insulin before you can rely on the active insulin calculation of the Bolus Wizard feature.
WARNING: Do not use Auto Mode for a period of time after giving a manual injection of insulin by syringe or pen. Manual injections are not accounted for in Auto Mode. Therefore, Auto Mode could deliver too much insulin. Too much insulin may cause hypoglycemia. Consult with your healthcare professional for how long you need to wait after a manual injection of insulin before you resume Auto Mode.
6
Chapter 1